High-throughput Screening for a Biosimilar N-Glycan Profile

biosimilarity, a high-throughput, sensitive assay with fast turnaround was needed to quickly screen N-glycan profiles in order to rank candidates to advance to the next stage of development. ProZyme’s GlykoPrep™ Rapid N-Glycan Sample Preparation (GlykoPrep) platform, coupled to fast analytical methods, was chosen to rapidly screen candidates to produce sensitive, accurate and precise results to assure a match with the N-glycan profile of the innovator molecule. We present an overview for screening from cell-line selection of a production cell line through cell-culture optimization. Results are shown for a series of cell-culture runs that targeted the desired N-glycan profile for a monoclonal antibody under various cell-culture conditions over multiple days, from shake flasks to small-scale bioreactors. The results revealed significant differences in N-glycosylation among the various conditions and over the growth time course. Using this approach, hundreds of samples per day may be quickly and reproducibly evaluated to move projects forward to completion.